The following data is part of a premarket notification filed by The Argen Corporation with the FDA for Argenis Titanium Abutments.
| Device ID | K143051 |
| 510k Number | K143051 |
| Device Name: | ArgenIS Titanium Abutments |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | THE ARGEN CORPORATION 5855 OBERLIN DRIVE San Diego, CA 92121 |
| Contact | Maria Rao |
| Correspondent | Maria Rao THE ARGEN CORPORATION 5855 OBERLIN DRIVE San Diego, CA 92121 |
| Product Code | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-10-23 |
| Decision Date | 2015-09-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D818120071 | K143051 | 000 |
| D818120069 | K143051 | 000 |
| D818120068 | K143051 | 000 |
| D818120067 | K143051 | 000 |